A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder (SOLEO)
Double-blind, randomized, placebo-controlled Phase II outpatient trial (n=90) evaluating CLE-100 (oral esketamine) 1 tablet once daily adjunctive to standard antidepressant therapy for 4 weeks in adults with MDD and inadequate response to ≥2 antidepressants.
Detailed Description
SOLEO is a Phase II, double-blind, randomized, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of oral esketamine (CLE-100) given once daily for 4 weeks as an adjunct to an ongoing oral antidepressant in adults with MDD who have had an inadequate response to at least two antidepressants.
Participants who complete the 4-week double-blind period and meet eligibility may roll over into a 6-month open-label extension with CLE-100. Assessments include MADRS, safety labs, vitals, C-SSRS, and other standard tolerability measures.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
CLE-100
experimentalCLE-100 (oral esketamine) 1 tablet once daily adjunctive to current antidepressant for 4 weeks.
Interventions
- Esketaminevia Oral• once daily• 28 doses total
1 tablet once daily for 4 weeks as adjunct to current oral antidepressant.
Placebo
placeboPlacebo tablet once daily adjunctive to current antidepressant for 4 weeks.
Interventions
- Placebovia Oral• once daily• 28 doses total
Matching placebo tablet once daily for 4 weeks as adjunct to current oral antidepressant.
Participants
Inclusion Criteria
- Inclusion Criteria:
- 1. Male or female between 18 to 65 years of age at Screening
- 2. Diagnosis of MDD, single or recurrent, without psychotic features, in the current or previous episode(s), according to DSM-5 and supported by the MINI Screen 7.0.2.
- 3. Currently experiencing a Major Depressive Episode that began at least 12 weeks but no more than 5 years prior to Screening; confirmed by independent SAFER assessor.
- 4. MADRS score ≥24 at Screening as confirmed by independent SAFER assessor.
- 5. History of inadequate response to at least 2 antidepressant medications in the current MDE (less than 50% improvement after ≥6 weeks at therapeutic dose), verified by medical/pharmacy records and independent SAFER assessor.
- 6. Able and competent to read and sign informed consent form (ICF).
Exclusion Criteria
- Exclusion Criteria:
- 1. History of inadequate response to more than 5 antidepressant medications in the current MDE.
- 2. High risk of suicide based on any of the following: Item 10 of MADRS score ≥5 at Screening/Baseline; suicide attempt in previous 6 months; significant risk judged by Investigator or C-SSRS information.
- 3. Current or lifetime history of substance use disorder with ketamine, PCP, LSD, or MDMA hallucinogen-related use disorders, or any other current substance use disorder or history within 12 months prior to Screening (DSM-5 criteria; excludes tobacco use disorder).
- 4. Recreational use of ketamine, esketamine, PCP, or dextromethorphan in past 6 months.
- 5. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other schizophrenia spectrum disorders.
- 6. Dementia, delirium, amnesia, or other significant cognitive disorder.
- 7. Any medical condition for which increases in blood pressure, intracranial pressure, intraocular pressure, or tachycardia pose serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage).
Study Details
- StatusActive not recruiting
- PhasePhase II
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment90 participants
- TimelineStart: 2024-03-18End: 2026-01-10
- Compounds
- Topic